JMS Wingeater A.v.fistula Needle SET
Wingeater A.v.fistula 16GX1" 30CM W/Clamp (Twin)
4manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Bain Medical Equipment(Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 3 |
| Vital Healthcare (Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | JMS Singapore PTE. Ltd, Singapore |
|---|---|
| FDA product code | FIE |
| Device type | Needle, Fistula |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment humidity 20 to 80 % RH; Handling environment temperature 5 to 30 °C |
| Packaging | Pack of 250, pack of 200 |
| Sizes | Needle gauge 14 to 18 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 820-2632-33 | Needle Gauge 16 G | In distribution |
| 820-1476-33 | Needle Gauge 14 G | In distribution |
| 820-2717-33 | Needle Gauge 17 G | In distribution |
| 820-2402-33 | Needle Gauge 14 G | In distribution |
| 820-2531-33 | Needle Gauge 15 G | In distribution |
| 820-6014-33 | Needle Gauge 16 G | In distribution |
| 820-6015-33 | Needle Gauge 16 G | In distribution |
| 820-5003-33 | Needle Gauge 15 G | In distribution |
| 820-1844-33 | Needle Gauge 18 G | In distribution |
| 820-7001-33 | Needle Gauge 17 G | In distribution |
| 820-5006-33 | Needle Gauge 15 G | In distribution |
| 820-7002-33 | Needle Gauge 17 G | In distribution |
| 820-5002-33 | Needle Gauge 15 G | In distribution |
| 820-6013-33 | Needle Gauge 16 G | In distribution |
| 820-7005-33 | Needle Gauge 17 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medisystems Hemodialysis Fistula Needle Set with MasterGuard | Medisystems Corp. | 72 |
| Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard | Medisystems Corp. | 44 |
| masterguard plus Hemodialysis Fistula Needle SET | Nxstage Medical, Inc. | 35 |
| masterguard plus Twinpack+ Hemodialysis Fistula Needle Sets | Nxstage Medical, Inc. | 20 |
| Dora | Bain Medical Equipment(Guangzhou) Co., Ltd. | 17 |
| Medisystems Button Hole Needle Set | Medisystems Corp. | 14 |
| ButtonHole with SteriPick Twinpack+ Needle SET | Nxstage Medical, Inc. | 14 |
| Medisystems TwinPack ButtonHole Needle Set with SteriPick | Medisystems Corp. | 14 |
| ButtonHole with SteriPick Needle SET | Nxstage Medical, Inc. | 14 |
| Medisystems Button Hole Needle Set with SteriPick | Medisystems Corp. | 14 |
| JMS A.V. Fistula Needle SET | JMS Singapore PTE. Ltd | 11 |
| JMS Harmony A.v.fistula Needle SET | JMS Singapore PTE. Ltd | 10 |
Showing 12 of 32. All products under Needle, Fistula
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.